MedShape, Inc. now has a new material platform known as PEEK Scoria, which involves a new process to grow a controlled porous layer on the surface of PEEK. While porous metals have found their way into clinically used devices, MedShape is the first company to develop and clear through the FDA devices manufactured with porous PEEK. The Morphix SP Suture Anchor, the first device manufactured from PEEK Scoria, recently received FDA 510(k) clearance.
Developed by a group of scientists and engineers at the Georgia Institute of Technology, PEEK Scoria contains pores only on the top millimeter of the surface. PEEK Scoria is processed using Zeniva PEEK resin from Solvay Specialty Polymers, a world leader in high-performance polymer technology. The technology was also developed at Georgia Tech through a grant from Solvay.
The proprietary technology, licensed from Georgia Tech by MedShape, increases the contact area with adjacent biologic tissue without compromising the mechanical integrity of the device itself. PEEK Scoria has the following key material characteristics:
- 65% porosity
- 300um average pore size
- 99% interconnectivity
- 2X shear strength of trabecular bone
- Comparable fatigue strength and modulus to traditional PEEK
The presence of an open cell structure has shown to be advantageous for supporting biologic tissue in-growth around a material. Porous materials are a class of structured materials associated with promoting adjacent tissue in-growth. However, the mechanical properties of porous materials, particularly porous polymers, are inherently reduced compared to their bulk material counterpart, limiting their use, to date, in load-bearing applications. Unlike traditional porous materials, PEEK Scoria contains porosity only on the top 1mm surface layer and exhibits mechanical strength and fatigue resistance comparable to regular PEEK and greater than clinically-used porous metals. PEEK is a widely used material in biomedical implants because of its excellent mechanical properties, radiolucency, and biocompatibility. However, PEEK does not actively interact with bone tissue.
Professor Bob Guldberg, is the director of the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Institute of Technology, and a world-renowned expert in biomaterials and device osseointegration. Professor Guldberg has recently studied bony ingrowth in PEEK Scoria and results of his work will be presented at the Orthopaedic Research Society Annual Meeting in March. “The preliminary data demonstrate bony ingrowth into the porous PEEK network. Future studies will include a fundamental understanding of the extent of osseointegration and soft tissue attachment and the impact of the release of biologic agents from the porous network.”
Morphix SP is the first product to feature the technology. Morphix SP has the same design and performance benefits as its predecessor (Morphix) but includes a porous layer at the top of the implant at the interface between soft tissue and bone.
MedShape will be showcasing PEEK Scoria and Morphix SP at the upcoming American Academy of Orthopaedic Surgeons Annual Conference in New Orleans.
Ken Gall, Ph.D., professor of Mechanical Engineering and Materials Science at Georgia Institute of Technology and also chief technology officer at MedShape, told OTW, “PEEK Scoria is an exciting new technology platform for MedShape that is backed by extensive university biomaterials research. We were excited to discover a new processing method that seamlessly connects a porous surface to a solid base while maintaining the mechanical strength and stiffness of the base material. The clearance of the Morphix SP device represents an important first step in designing future polymer devices to provide both mechanical function along with a local surface that promotes biological repair and function in a high-strength, non-resorbable device.”
